Cervical Foraminal StenosisNCT05326698
Evoked Potential Response to Full-endoscopic Cervical Foraminotomy
An observational study of Cervical Foraminal Stenosis, run by Centre Hospitalier Régional de la Citadelle at 1 site in Belgium.
Trial summary
Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Foraminal Stenosis
- What is being tested?
- Medtronic NIM Eclipse for evoked potentials recording
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Feb 2022to 24 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: 3 patients will undergo endoscopic surgery on February 22 and 23, 2022 for a cervical foraminotomy to treat foraminal stenosis responsible for recalcitrant cervicobrachial pain. These surgeries will be performed with pre-, per- and post-operative recording of motor and sensory evoked potentials.
Who may be able to join
- Cervical radiculopathy due to foraminal stenosis
- Age > 18 years
- Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
- Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
- Intact Llemniscal pathways must remain at least partially intact
Who cannot join
- History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
- Presence of myelopathy
- Addiction to drugs, alcohol (5 units/day) and/or medications
Trial locations and contacts
1 site in 1 country.
About this study
Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy
- Conditions
- Cervical Foraminal Stenosis
- Being tested
- Medtronic NIM Eclipse for evoked potentials recording
- Keywords
- Evoked Potential, Endoscopy, Irrigation pressure, Dorsal columns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic NIM Eclipse for evoked potentials recordingProcedure or surgery
Also called Joimax Ilessys Pro for endoscopic cervical foraminotomy
Recording of somesthetic and motor evoked potentials during endoscopic posterior cervical foraminotomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.
The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder.
The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back.
Somatosensory evoked potentials (SEP) were recorded continuously from electrode placement to electrode removal.
The blood pressure and the irrigation pressure in the endoscope are also continuously recorded.
A change SEP in latency and/or amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.
Measured: Through surgery completion, from electrodes placement until their removal. An average of two hours.
Influence of the endoscopic irrigation pressure on motor evoked potentials.
The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder.
The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back.
Motor evoked potentials (MEP) were recorded at each step of the surgery (preoperative, skin incision, working tube placement, endoscope introduction, and foraminotomy) and also at each variation of the irrigation pressure.
A change MEP amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.
Measured: Through surgery completion, from electrodes placement until their removal. An average of two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start22 Feb 2022
- Primary completion23 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Foraminal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional de la Citadelle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remacle Thibault, Centre Hospitalier Régional de la Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326698
- Sponsor's protocol ID
- Evoked cervical endoscopy
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evoked Potential Response to Full-endoscopic Cervical Foraminotomy
- ClinicalTrials.gov ID
- NCT05326698
- Acronym / sponsor ID
- Evoked cervical endoscopy
- Conditions
- Cervical Foraminal Stenosis
- Keywords
- Evoked Potential, Endoscopy, Irrigation pressure, Dorsal columns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional de la CitadelleUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- 3 patients will undergo endoscopic surgery on February 22 and 23, 2022 for a cervical foraminotomy to treat foraminal stenosis responsible for recalcitrant cervicobrachial pain. These surgeries will be performed with pre-, per- and post-operative recording of motor and sensory evoked potentials.
Key inclusion criteria (5 listed)
- Cervical radiculopathy due to foraminal stenosis
- Age > 18 years
- Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
- Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
- Intact Llemniscal pathways must remain at least partially intact
Key exclusion criteria (3 listed)
- History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
- Presence of myelopathy
- Addiction to drugs, alcohol (5 units/day) and/or medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic NIM Eclipse for evoked potentials recordingAlso: Joimax Ilessys Pro for endoscopic cervical foraminotomyRecording of somesthetic and motor evoked potentials during endoscopic posterior cervical foraminotomy. | Procedure or surgery | – |
Primary outcome
Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.
Time frame: Through surgery completion, from electrodes placement until their removal. An average of two hours.
The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder. The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back. Somatosensory evoked potentials (SEP) were recorded continuously from electrode placement to electrode removal. The blood pressure and the irrigation pressure in the endoscope are also continuously recorded. A change SEP in latency and/or amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.
Influence of the endoscopic irrigation pressure on motor evoked potentials.
Time frame: Through surgery completion, from electrodes placement until their removal. An average of two hours.
The evoked potentials electrodes were placed once the patient was asleep under general anesthesia, installed in a prone position in a Mayfield head holder. The electrodes were removed at the end of surgery after skin closure but before removing the headrest and returning the patient to his back. Motor evoked potentials (MEP) were recorded at each step of the surgery (preoperative, skin incision, working tube placement, endoscope introduction, and foraminotomy) and also at each variation of the irrigation pressure. A change MEP amplitude could therefore be detected during the entire recording and related to variations in irrigation pressure and intraoperative events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Foraminal Stenosis, run by Centre Hospitalier Régional de la Citadelle at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of the endoscopic irrigation pressure on somatosensory evoked potentials. (time frame: Through surgery completion, from electrodes placement until their removal. An average of two hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.